Nalox-Comm: Naloxone Communication Training for Pharmacists

NCT ID: NCT04677387

Last Updated: 2024-06-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-07-31

Brief Summary

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This is a pilot Randomized Controlled Trial (RCT) in which 120 pharmacists will be randomized to an experimental or control group and data on naloxone dispensing and secondary outcomes will be collected over the course of the RCT.

Detailed Description

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This is a prospective pilot RCT that will evaluate the impact of naloxone communication training (Nalox-Comm) on 120 pharmacists' naloxone dispensing behaviors (primary outcome). Data will be collected at baseline, immediately after training is completed, and at 3-month follow up. Data sources include pharmacy records (for naloxone dispensing), simulated patient observations (to rate quality of communication), and survey data (for self-reports of knowledge and self-efficacy).

Conditions

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Naloxone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Prescribe to Prevent Naloxone Training Module

This a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists.

Group Type PLACEBO_COMPARATOR

Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists

Intervention Type BEHAVIORAL

A 55 minute long online module with videos, didactic content, and quizzes that covers the following topics: risk factors for overdose (OD), how to respond to OD, how naloxone works, types of naloxone, how to administer naloxone, medico-legal issues, how to bill for naloxone, and strategies to address overdose. Pharmacists can receive continuing education credit (0.125 CEUs) for completing the course.

Nalox-Comm

This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers.

Group Type EXPERIMENTAL

Nalox-comm Training Module

Intervention Type BEHAVIORAL

The online communication module will be 30-60 minutes. Content will include: 1) using non-judgmental language, 2) how to raise the topic of overdose (OD) and naloxone with patients in a non-threatening manner; 3) videos modeling how to initiate the conversation with patients and caregivers; 4) considerations in how to communicate differently with patients versus caregivers; and 5) addressing pharmacists' perceived barriers to naloxone counseling. Pharmacists can receive continuing education credit (0.1 CEU) for completing the course.

Interventions

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Nalox-comm Training Module

The online communication module will be 30-60 minutes. Content will include: 1) using non-judgmental language, 2) how to raise the topic of overdose (OD) and naloxone with patients in a non-threatening manner; 3) videos modeling how to initiate the conversation with patients and caregivers; 4) considerations in how to communicate differently with patients versus caregivers; and 5) addressing pharmacists' perceived barriers to naloxone counseling. Pharmacists can receive continuing education credit (0.1 CEU) for completing the course.

Intervention Type BEHAVIORAL

Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists

A 55 minute long online module with videos, didactic content, and quizzes that covers the following topics: risk factors for overdose (OD), how to respond to OD, how naloxone works, types of naloxone, how to administer naloxone, medico-legal issues, how to bill for naloxone, and strategies to address overdose. Pharmacists can receive continuing education credit (0.125 CEUs) for completing the course.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* currently work at a pharmacy that stocks naloxone;
* currently work at a rural community pharmacy;
* are at least 18 years of age; and
* speak English.

Exclusion Criteria

* Non-staff pharmacists such as pharmacy "floaters" or fill-in pharmacists will not be eligible to participate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delesha Carpenter, PhD, MSPH

Role: PRINCIPAL_INVESTIGATOR

UNC Eshelman School of Pharmacy

Locations

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University of North Carolina at Chapel Hill (Asheville campus)

Asheville, North Carolina, United States

Site Status

Countries

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United States

References

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Thornton JD, Lyvers E, Scott VGG, Dwibedi N. Pharmacists' readiness to provide naloxone in community pharmacies in West Virginia. J Am Pharm Assoc (2003). 2017 Mar-Apr;57(2S):S12-S18.e4. doi: 10.1016/j.japh.2016.12.070. Epub 2017 Feb 2.

Reference Type BACKGROUND
PMID: 28163027 (View on PubMed)

Hagemeier NE, Murawski MM, Lopez NC, Alamian A, Pack RP. Theoretical exploration of Tennessee community pharmacists' perceptions regarding opioid pain reliever abuse communication. Res Social Adm Pharm. 2014 May-Jun;10(3):562-75. doi: 10.1016/j.sapharm.2013.07.004. Epub 2013 Aug 24.

Reference Type BACKGROUND
PMID: 23981913 (View on PubMed)

Gamm L, Stone S, Pittman S. Mental health and mental disorders-A rural challenge: A literature review. Rural healthy people. 2010;1:97-114.

Reference Type BACKGROUND

Browne T, Priester MA, Clone S, Iachini A, DeHart D, Hock R. Barriers and Facilitators to Substance Use Treatment in the Rural South: A Qualitative Study. J Rural Health. 2016 Winter;32(1):92-101. doi: 10.1111/jrh.12129. Epub 2015 Jul 15.

Reference Type BACKGROUND
PMID: 26184098 (View on PubMed)

Freeman PR, Goodin A, Troske S, Strahl A, Fallin A, Green TC. Pharmacists' role in opioid overdose: Kentucky pharmacists' willingness to participate in naloxone dispensing. J Am Pharm Assoc (2003). 2017 Mar-Apr;57(2S):S28-S33. doi: 10.1016/j.japh.2016.12.064. Epub 2017 Jan 28.

Reference Type BACKGROUND
PMID: 28139459 (View on PubMed)

Mueller SR, Koester S, Glanz JM, Gardner EM, Binswanger IA. Attitudes Toward Naloxone Prescribing in Clinical Settings: A Qualitative Study of Patients Prescribed High Dose Opioids for Chronic Non-Cancer Pain. J Gen Intern Med. 2017 Mar;32(3):277-283. doi: 10.1007/s11606-016-3895-8. Epub 2016 Oct 31.

Reference Type BACKGROUND
PMID: 27798775 (View on PubMed)

Nielsen S, Menon N, Larney S, Farrell M, Degenhardt L. Community pharmacist knowledge, attitudes and confidence regarding naloxone for overdose reversal. Addiction. 2016 Dec;111(12):2177-2186. doi: 10.1111/add.13517. Epub 2016 Aug 16.

Reference Type BACKGROUND
PMID: 27367125 (View on PubMed)

Liekens S, Vandael E, Roter D, Larson S, Smits T, Laekeman G, Foulon V. Impact of training on pharmacists' counseling of patients starting antidepressant therapy. Patient Educ Couns. 2014 Jan;94(1):110-5. doi: 10.1016/j.pec.2013.09.023. Epub 2013 Oct 12.

Reference Type BACKGROUND
PMID: 24169022 (View on PubMed)

Alte D, Weitschies W, Ritter CA. Evaluation of consultation in community pharmacies with mystery shoppers. Ann Pharmacother. 2007 Jun;41(6):1023-30. doi: 10.1345/aph.1H565. Epub 2007 May 22.

Reference Type BACKGROUND
PMID: 17519295 (View on PubMed)

Weiss MC, Booth A, Jones B, Ramjeet S, Wong E. Use of simulated patients to assess the clinical and communication skills of community pharmacists. Pharm World Sci. 2010 Jun;32(3):353-61. doi: 10.1007/s11096-010-9375-z. Epub 2010 Mar 18.

Reference Type BACKGROUND
PMID: 20238164 (View on PubMed)

Madden JM, Quick JD, Ross-Degnan D, Kafle KK. Undercover careseekers: simulated clients in the study of health provider behavior in developing countries. Soc Sci Med. 1997 Nov;45(10):1465-82. doi: 10.1016/s0277-9536(97)00076-2.

Reference Type BACKGROUND
PMID: 9351137 (View on PubMed)

Bjornsdottir I, Granas AG, Bradley A, Norris P. A systematic review of the use of simulated patient methodology in pharmacy practice research from 2006 to 2016. Int J Pharm Pract. 2020 Feb;28(1):13-25. doi: 10.1111/ijpp.12570. Epub 2019 Aug 9.

Reference Type BACKGROUND
PMID: 31397533 (View on PubMed)

Wilson JD, Spicyn N, Matson P, Alvanzo A, Feldman L. Internal medicine resident knowledge, attitudes, and barriers to naloxone prescription in hospital and clinic settings. Subst Abus. 2016 Jul-Sep;37(3):480-487. doi: 10.1080/08897077.2016.1142921. Epub 2016 Jan 28.

Reference Type BACKGROUND
PMID: 26820604 (View on PubMed)

Williams AV, Strang J, Marsden J. Development of Opioid Overdose Knowledge (OOKS) and Attitudes (OOAS) Scales for take-home naloxone training evaluation. Drug Alcohol Depend. 2013 Sep 1;132(1-2):383-6. doi: 10.1016/j.drugalcdep.2013.02.007. Epub 2013 Feb 28.

Reference Type BACKGROUND
PMID: 23453260 (View on PubMed)

Strahan R, Gerbasi K. Short, homogenous version of the Marlowe-Crowne social desirability scale. Journal of Clinical Psychology. 1972;28(191):193.

Reference Type BACKGROUND

Diggle P, Heagerty P, Liang K-Y, Zeger S. Analysis of longitudinal data. Oxford University Press; 2002.

Reference Type BACKGROUND

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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R34DA046598

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-2192

Identifier Type: -

Identifier Source: org_study_id

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